Optimizing Treatment and Advanced Multi-Imaging Response Evaluation for Very-High-Risk Prostate Cancer (OPTIMAL) - a Phase II Single Arm Study
Northwestern University
Summary
This phase II trial tests how well relugolix and enzalutamide, in combination with radiation therapy, works in treating patients with very high risk prostate cancer. Relugolix is a form of androgen deprivation therapy. It prevents the release of testosterone, a hormone required to sustain prostate growth. Reducing testosterone levels may inhibit the proliferation of prostate tumor cells that need testosterone to grow. Enzalutamide is an androgen receptor signaling inhibitor. It inhibits the activity of prostate tumor cell receptors, which may reduce proliferation of prostate tumor cells. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Adding relugolix and enzalutamide to radiation therapy may be more effective at treating patients with very high risk prostate cancer than giving any of these treatments alone.
Description
PRIMARY OBJECTIVE: I. To determine the efficacy of radiation therapy (RT) with androgen deprivation therapy (ADT) (relugolix) and an androgen receptor signaling inhibitor (enzalutamide), for a total duration of 18 months, in patients with National Comprehensive Cancer Network (NCCN) very high-risk prostate cancer, as determined by a 2-year biopsy positivity rate. SECONDARY OBJECTIVES: I. To determine the 4-year disease free survival (DFS) (biochemical failure of prostate specific antigen \[PSA\] nadir +2ng/mL, local or regional recurrence, distant metastasis, or death from any cause). II.…
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Patients must have histologically confirmed prostate adenocarcinoma consistent with NCCN very-high-risk (VHR) prostate cancer defined with at least one of the following: * cT3b-cT4 (American Joint Committee on Cancer \[AJCC\] 9.0) * \> 4 cores with grade group 4 or 5 prostate cancer * Primary gleason pattern 5 * 2 or 3 NCCN high-risk features. * Patients with involved pelvic lymph nodes below the common iliac bifurcation will be allowed as long as the criteria for VHR (very-high risk) are met * Patients must be age ≥ 18 years * Patients must have testosterone \>…
Interventions
- ProcedureBiopsy
Undergo biopsy
- ProcedureBiospecimen Collection
Undergo collection of blood samples
- ProcedureComputed Tomography
Undergo CT
- DrugEnzalutamide
Given PO
- OtherFluorine F 18 Piflufolastat
Undergo fluorine F 18 piflufolastat PET/MRI
- RadiationImage Guided Radiation Therapy
Undergo IGRT
- ProcedureMagnetic Resonance Imaging
Location
- Northwestern UniversityChicago, Illinois